Attached files

file filename
8-K - 8-K - MEDICINES CO /DEa12-29568_18k.htm

Exhibit 99.1

 

GRAPHIC

THE MEDICINES COMPANY BUILDING THE GLOBAL LEADER IN ACUTE AND INTENSIVE CARE MEDICINE Update for Investors December 17th – 20th 2012

 


GRAPHIC

Notices Forward looking statements Statements contained in these slides about The Medicines Company (the “Company”), the Company's products and product candidates, the timing of clinical trial results, regulatory submissions, product or indication launches, the Company’s future financial and operating results, and future opportunities for the Company, that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes", "anticipates", "plans", "expects", "intends", "potential", "estimates" , "outlook" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include the extent of the commercial success of the Company’s products and, upon approval, its product candidates; the Company’s ability to develop its global operations and penetrate foreign markets; whether the Company's products will advance in the clinical trials process on a timely basis or at all; whether the Company will make regulatory submissions for its products and product candidates on a timely basis; whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, including approvals for Ionsys and for Recothrom in jurisdictions other than the United States and Canada; whether physicians, patients and other key decision makers will accept clinical trial results; risks related to the Company’s dependence on Bristol-Myers Squibb to manufacture and supply Recothrom products during the collaboration term; the Company’s ability to successfully manufacture Recothrom products after it completes the acquisition of the manufacturing assets; the ability of Bristol-Myers Squibb and the Company and Incline and the Company to complete the transactions; the ability of the Company to obtain third-party consents necessary for the transfer of the acquired assets; the ability of the Company to successfully integrate the Recothrom and Incline businesses with its other businesses; the ability of the Company to retain certain key employees in the transactions; the conditions to the completion of the transactions, including the receipt of certain consents required in connection with the transactions that may not be obtained on the terms expected or on the anticipated schedule, including without limitation approval of the transactions under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended; the parties’ ability to meet expectations regarding the timing, completion and accounting and tax treatments of the transactions; and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on November 9, 2012, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements. Non GAAP financial measures The Company believes that presenting the non-GAAP information contained in this presentation assists investors and others in gaining a better understanding of the Company’s core operating results. Management uses this non-GAAP information, in addition to the GAAP information, as the basis for measuring the Company’s core operating performance and comparing such performance to that of prior periods and to the performance of its competitors. Such measures are also used by management in its financial and operating decision-making. Non-GAAP information is not meant to be considered superior to or a substitute for the Company’s results of operations prepared in accordance with GAAP. A reconciliation of non-GAAP measures referred to in this presentation is provided in the Investor Relations section of the Company’s website at www.themedicinescompany.com.

 


GRAPHIC

Contents Last week MDCO announced two significant transactions for growth PART I SUMMARY PART II BACKGROUND | RATIONALE | PROCESS Our focus on acute | intensive hospital medicine remains constant Building an acute | intensive care portfolio Progress since 2010 8 10 12 PART III STRATEGIC FIT Criteria for innovation Recothrom® Ionsys® 14 15 18 PART IV OPERATING LEVERAGE MDCO a leading hospital company – adding human talent with these deals 26 PART V DE-RISKED STRUCTURES Low development risk and structured financial arrangements reduce early exposure Both assets have favorable risk profiles 28 29 PART VI EFFECTIVELY TIMED REVENUE, CASH-FLOW AND EARNINGS GROWTH Accretion and growth over the short and long term 31 PART VII PRINCIPLES OF INTEGRATION – MOVING FORWARD PART VIII SUMMARY AND IMMEDIATE STEPS

 


GRAPHIC

SUMMARY

 


Summary What did we acquire...? Two potentially segment-leading assets in the acute | intensive care surgical market. Anticipated closing 1Q13. Subject to regulatory review. Recombinant human thrombin & applicators Topical aid to hemostasis in surgery Marketed in the United States and Canada Estimated net revenue in 2012 ~$70M; growing Worldwide rights (not yet approved ex-US) Exclusivity in US to 2020 | Ex-US 10y data excl. Approximately 85 associates Iontophoretic delivery system for fentanyl Transdermal patient controlled analgesia Pre-sNDA – anticipated launch in 2014 Estimated peak net revenue >$800M p.a. Worldwide rights (launched & withdrawn in EU) Worldwide patent estate to 2024 | 2031 Approximately 27 associates Bristol Myers Squibb’s - Recothrom® License & option to purchase rights | selected assets Incline Therapeutics’ – Ionsys® Incline becomes wholly owned subsidiary of MDCO

 


Summary What did we pay...? Total of $300M cash upfront. Both deals include downstream payments if products are successful Upfront collaboration payment $105M Upfront option fee $10M Tiered royalties for 2 years Double digit % Purchase price based on 2013-14 sales nd Total purchase price estimate 3.0 – 3.2x 2012 net revenue Bristol Myers Squibb’s - Recothrom® License & option to purchase rights | selected assets Upfront consideration $185M Earn out contingent milestone payments US approval nd EU approval nd Japanese partnership nd Net sales attainment (2 tranches) nd Total earn out consideration $205M Total purchase price estimate $390M Incline Therapeutics’ – Ionsys® Incline becomes wholly owned subsidiary of MDCO nd = not disclosed

 


GRAPHIC

Summary What growth and financial consequences do we foresee from these deals...? Accretion | dilution Recothrom® deal is expected to be accretive to earnings in 2013 Incline Therapeutics deal is expected to be modestly dilutive for 2013-14 Combined the deals are neutral to slightly negative on a 2013 cash-flow basis Sustainable, attractive, revenue and – because these new products fit an established commercial channel – earnings growth These new products have the potential to drive immediate and long-term growth Accelerate near-term revenue growth “Fill the gap” around 2019 when Angiomax® US exclusivity is anticipated to become shared Potential for long-term exclusivity and continued growth of Ionsys beyond 2024 based on recently granted IP Non-risk adjusted revenue estimates for 2013 - 2025 Illustrative company estimates including all products in current portfolio New products are Recothrom® and Ionsys®

 


GRAPHIC

BACKGROUND | RATIONALE | PROCESS

 


Implementation of strategy Our focus on acute | intensive hospital care remains constant Strategy articulated since 2006 Expected to create significant value for shareholders Purpose To save lives, alleviate suffering and improve the economic efficiency of the ~2,500 leading acute | intensive care hospitals in the world Vision To become the leading provider of solutions for acute | intensive care hospitals worldwide, specifically focused on improving health and economic outcomes: Acute cardiac events Neuro-intensive care Life-threatening infection Trauma Major surgery Goals To deliver industry-leading metrics for: Value to hospital customers Acute | intensive care portfolio depth and breadth People performance Financial performance Worldwide 68M deaths projected in 2030 World Health Organization 175 367 103 212 41 450 USA D | F | I | UK | NL | CH E | Pl | Be | Cz China | India | Brazil | Canada | Australia A | Sw No | Dk Fi | Tk Hu | Gr UAE Total Japan ~80% of acute care delivered in ~2,500 hospitals MDCO | McKinsey Top tier Second tier

 


GRAPHIC

Implementation of strategy Our focus on acute | intensive hospital care remains constant Scope of business development activities since 2006: more than 500 assets reviewed PHARM Pharmacy Services ECARD ECG diagnostics BBANK Blood Bank CTSCA Computer. Tomograph Imaging MRI Magnetic Resonance Imaging ULTSD Ultrasound imaging Dr.I Diagnostic isotope. imaging PET PET Scan Imaging I II Adjacent business III Potential expansion categories Source: Verispan; MDCO analysis Anchor business in PCI IV

 


GRAPHIC

Implementation of strategy Building an acute | intensive care portfolio Twenty assets acquired or invested-in Name Route Class Patients Stage Launch (e = est.) 2012 sales (estimated) Peak sales (estimated) Angio(ma)x® (bivlairudin) Injectable Thrombin inhibitor anticoagulant Patients undergoing percutaneous coronary interventions Marketed in US, Europe, India, Austr. 2001 $530-535M $750M Recothrom® Topical Thrombin sealant Patients undergoing surgery US 2006 $70M $100-115M+ Cleviprex® 12h (clevidipine) Injectable L-calcium channel antagonist Patients with hypertension when oral agents are not feasible or desirable US 2012 $3M $200M RTU Argatroban Injectable Thrombin inhibitor anticoagulant Patients with or at risk of HIT-HITTS US 2011 $5M tbd 10 generics Injectable Various Various Pre-launch 2013e tbd Ionsys® Transdermal Opioid analgesic Patients undergoing surgery Approved, not launched 2014e $800M+ MDCO157 clopidogrel IV Injectable Platelet inhibitor anticoagulant Patients undergoing percutaneous coronary interventions Phase III 2014e $100M Cangrelor Injectable Platelet inhibitor anticoagulant Patients undergoing percutaneous coronary interventions or bridge to surgery Phase III 2014e $450M Oritavancin Injectable Gram positive antibiotic Patients with ABSSSI Subsequent indications Phase III 2014e $400M MDCO216 ApoA-I Milano Injectable Reverse cholesterol transport agent Patients with high risk ACS Phase I 2019e tbd Annovation investment Inhaled Anesthetics Surgery Phase 0 2017e tbd

 


GRAPHIC

Implementation of strategy Building an acute | intensive care portfolio Assets can serve similar audiences – interventional cardiology, surgery, emergency room, perioperative care Name Route Class Patients Principal audience Angio(ma)x® (bivlairudin) Injectable Thrombin inhibitor anticoagulant Patients undergoing percutaneous coronary interventions Interventional cardiology Recothrom® Topical Thrombin sealant Patients undergoing surgery Surgery Cleviprex® 12h (clevidipine) Injectable L-calcium channel antagonist Patients with hypertension when oral agents are not feasible or desirable Surgery | Emergency room | Perioperative care RTU Argatroban Injectable Thrombin inhibitor anticoagulant Patients with or at risk of HIT-HITTS Surgery | Perioperative care 10 generics Injectable Various Various Surgery | Emergency room | Perioperative care Ionsys® Transdermal Opioid analgesic Patients undergoing surgery Surgery | Perioperative care MDCO157 clopidogrel IV Injectable Platelet inhibitor anticoagulant Patients undergoing percutaneous coronary interventions Interventional cardiology Cangrelor Injectable Platelet inhibitor anticoagulant Patients undergoing percutaneous coronary interventions or bridge to surgery Interventional cardiology | Surgery | Perioperative care Oritavancin Injectable Gram positive antibiotic Patients with ABSSSI Subsequent indications Surgery | Emergency room | Perioperative care MDCO216 ApoA-I Milano Injectable Reverse cholesterol transport agent Patients with high risk ACS Interventional cardiology Annovation investment Inhaled Anesthetics Surgery Surgery

 


GRAPHIC

Implementation of strategy Progress since 2010 2010 3Q - Angiomax® US exclusivity period clarified Reaffirmed growth strategy 2012 3Q - raised $275M in convertible debt offering. End 3Q 2012, $535M Before these deals -- we expected to end the year 2012 at $560-$565M cash in hand 2012 2Q - reinforced depth and breadth of our New Business Ventures team Added to our expertise in surgical medicine, devices and deal execution 2012 2Q - reaffirmed criteria for business development targets Strategic fit: Acute or intensive care assets with authentic potential to create value for hospitals Operating leverage: Fit in our existing commercial channel and third party manufacturing feasible De-risked: Late stage or marketed | back-ended financial structures | reasonable overall consideration Effective timing: Growing assets, non-dilutive, providing opportunities to sustain growth beyond 2019 Recothrom® and Ionsys® appeared almost simultaneously earlier this year Both of these deals fulfill all of our key criteria in even the strictest sense We pursued both with the intention of acquiring both

 


GRAPHIC

III STRATEGIC FIT

 


GRAPHIC

Strategic fit Criteria for innovation All of our criteria for a fit with our growing business were met for both products Criteria Recothrom® Ionsys® Overlapping institutions from our global target list 100% with Cleviprex® 100% with Cleviprex® Worldwide rights Yes Yes Effectiveness data available Yes – and approved on that basis Yes – once approved on that basis Safety advantage potential Low antigenic potential Reduced risk of medication errors Dosage and administration characteristics Range of application tools and methods Unique and highly innovative system Quality and manufacturing established Established supply chain with track record Revisions made to original engineering Risk-benefit criteria met Competitive Disruptive Cost-performance ratio potentially dominant Reduced potential cost of IMC Reduced medical errors and complexity Marketability profile favorable Winning market share since launch Strong original launch in Europe Exclusivity US exclusivity 2020 (biologic) US patents 2024 - 2031

 


GRAPHIC

Strategic fit Recothrom® Recothrom is a topical hemostat used as an aid to hemostasis to help control oozing blood and mild bleeding during surgical procedures. It is a recombinant version of the human blood-clotting protein thrombin (coagulation Factor Iia) Provides an effective and safe alternative to other thrombin products that are derived from bovine (cattle) plasma or pooled human plasma Very low immunogenicity and is inherently free of the risk of transmitting blood born pathogens Lyophilized powder dissolved in saline and either combined with an absorbable gelatin sponge or sprayed directly onto the surface The BLA for Recothrom was approved by the FDA on January 17, 2008 Previously marketed in the US by BMS and in Canada by Bayer HealthCare In March 2012, Bayer notified BMS of its intention to return all Recothrom product rights to BMS All rights in Canada are included in the scope of the Transaction Recothrom uses a patent-protected two-step process to purify the active ingredient rThrombin from recombinant human prethrombin-1 (rPrethrombin) Process is complex - uses a highly potent proprietary enzyme activator, making it challenging to replicate US market exclusivity through early 2020

 


Strategic fit Recothrom® Topical hemostats are biologic pharmaceuticals and medical devices that are used to control diffuse raw surface, oozing venous, bone, and suture needle-hole bleeding Topical hemostats are divided into four classes and each has around $200M in sales in the US market: Mechanical Absorbable gelatin sponge Collagen Cellulose polysaccharide Microspheres Active hemostats Bovine thrombin Pooled human plasma thrombin Recombinant thrombin Flowable hemostats Gelatin matrix Gelatin matrix plus thrombin Fibrin sealants Pooled plasma derived fibrinogen and thrombin Active hemostats market Competitors to Recothrom are Thrombin-JMI, marketed by Pfizer, Inc., a bovine pooled plasma thrombin, and Evithrom, marketed by Ethicon, Inc., a human pooled plasma thrombin US sales of topical thrombin products was $205 million in 2011 Topical thrombin usage has experienced downward price pressures in recent years due to competition Thrombin JMI maintains about 60% of the topical thrombin market as of 2011, but Recothrom’s market share has increased from 3% in 2008 to an estimated 35% in 2012

 


Strategic fit Recothrom® A range of presentations offer growth opportunities Absorbable gelatin sponge Gelfoam® sponge Surgifoam® sponge Absorbable gelatin matrix Surgiflo® hemostatic matrix Absorbable gelatin powder Surgifoam® powder Gelfoam® powder Pump spray device Single spray device New development potential – e.g. Pad Minimally invasive Flowable

 


GRAPHIC

Strategic fit Ionsys® Post-operative pain product competing in the current ~$6B US/EU/Japan market Compact, needle-free, disposable patient controlled analgesia Late stage with US approval anticipated in Q1 2014 Peak revenue potential >$800M Strong leadership team with ALZA roots Potential to enable MDCO with broader Japanese access Developed at ALZA Underwent 36 clinical trials (including 7 Phase III trials) Pre-programmed, pre-loaded with 10 mg of fentanyl PK similar to IV infusion (40 ug per dose) Proven to have efficacy comparable to IV PCA, with attractive safety profile On-demand delivery via proprietary iontophoresis technology Only transdermal product suitable for acute post-op pain Others (e.g., Duragesic) contraindicated FDA/EMA approved 2006 for inpatient post-op pain Never launched in US due to corrosion risk; Recalled in Europe after encouraging market launch

 


GRAPHIC

Strategic fit Ionsys® Clinical pharmacology shows essentially bio-equivalence to IV fentanyl given every hour for 20 minutes iv Time (h) Serum fentanyl concentration (ng/mL) 1.5 1.0 0.5 0.0 0 4 8 12 16 20 24 28 32 36 40 44 48 IONSYS: 2 consecutive 40mcg doses/20 min Q1h IV fentanyl: 80mcg infusion/20 min Q1h

 


Strategic fit Ionsys®

Successfully completed phase III clinical trial program

Treatment success as measured by patient global assessment of pain control (%)Viscusi ER, et al. JAMA. 2004;291:1333-1341

Hartrick CT et al. Reg Anesth Pain Med. 2006;31(6):546-54

Minkowitz HS et al. Pain Medicine. 2006; 8(8):657-68 21

 


GRAPHIC

Strategic fit Ionsys® Published studies demonstrate economic dominance over intravenous PCA even in the HTA-oriented European arena Authors | presentation Country of study Main finding Annemans, EFIC 2006 Belgium €126-186 cost savings with IONSYS compared to IV PCA Standl, EFIC 2006 France, Germany, UK €96.40 cost for an average 1.6 day IV PCA episode based solely on consumables costs, pump costs, and staff time Van Bellinghen, SFAI 2008 Sweden IONSYS dominated the 1 and 2-day group and offered fewer complications at a higher cost in the 3-day group Van den Steen, ISPOR 2008 Finland IONSYS dominated the 1-day group and offered fewer complications at a higher cost in the 2-day and 3-day groups Wielback, WIP 2007 Germany €21 cost savings with IONSYS compared to IV PCA Yfantopolous, ISPOR 2007 Greece €40 cost savings with IONSYS compared to IV PCA From To

 


Strategic fit Ionsys® Original product had problems with humidity in packaging This led to corrosion of electronic contacts EMA approved product with dessicant in package FDA approved product, not launched EMA recall in September 2008 due to corrosion Separated system created PK study established bioequivalence Separated system not pursued Divested to Incline – venture backed start up in 2010 Incline Therapeutics developed the separated system Enhanced reliability preventing potential causes of failure Improves usability – e.g. displays dose delivered on LCD display No changes related to drug delivery Regulatory agreements in place PK bridging | human factors studies underway Reliability enhancements CMC comparability and stability REMS Proprietary manufacturing lines transferred 1st line up and running at DPT (NJ) 2 back up or expansion lines in storage Current Incline system Separated assembly Other enhancements Original approved system Pouch humidity Single assembly Corrosion problems

 


GRAPHIC

Strategic fit Ionsys® Rapid timeline to market anticipated – in all three regions US milestones PK bridging study Q2 2013 Practitioner/patient usability study Q2 2013 sNDA submission Q4 2013 CMC supplement - 4-month review Q4 2013 REMS supplement - 6-month review Q1 2014 US launch anticipated Q2 2014 EU milestones PK bridging study Q2 2013 MAA submission Q4 2013 MAA approval Q4 2014 EU launch Early 2015 Japan milestones (subject to partnership) Initiate Phase III study in Japan Q1 2014 Phase III results Q4 2014 Japan launch 2016 - 2017

 


GRAPHIC

Strategic fit Ionsys® Competitive review Company Product Description Marketed Cadence Ofirmev Stable formulation of intravenous acetaminophen Pacira Exparel Delivers post surgical pain control with reduced opioid requirement for up to 72 hours Cornerstone / EKR DepoDur Extended release epidural morphine PCA Multiple opioids Other Modalities Multiple drugs In development Durect Posidur (phase III) Releases therapeutic levels of bupivacaine, providing 72 hours of pain relief • Potential NDA submission at the end of 2012 • Hospira returned rights on April 2, 2012 Cara CR845 (phase II) Highly selective for the peripheral kappa opioid receptor • Effective for treating pain of inflammatory, neuropathic and visceral origin • Phase 3 trial expected in 2013 AcelRx ARX01 (phase III) Sublingual sufentanil nano-tab technology

 


GRAPHIC

IV OPERATING LEVERAGE

 


GRAPHIC

Operating leverage MDCO is a leading hospital company – adding human talent with these deals Unique organization – built stepwise and specifically to address the unique challenges of acute and intensive care Collaboration with AstraZeneca - supporting their efforts to sell Brilinta in US hospitals. These next two transactions provide further operating leverage – this time for our US, European, and emerging Asia-Pacific organizations built initially around Angio(ma)x and Cleviprex® Identical channel to Cleviprex® Recothrom® team of ~45 representatives will augment Cleviprex sales efforts Proven themselves effective in the perioperative environment Now with the added opportunity of a broad, innovative portfolio Potential to become leaders in perioperative medicine, similar to our clear leadership position in the cath lab with Angiomax Cleviprex team of 15 has been increasingly successful in 2012 From Incline Therapeutics, we are also adding world class capability of 27 highly expert employees in engineering, clinical development, regulatory affairs and commercial activities related to post-operative analgesia Manufacturing and logistics resources for both products are established – and efficient Recothrom manufacturing is outsourced by BMS who will oversee the third party manufacturing for the next 2-years during the term of our alliance. Ionsys® manufacturing will be done by a third party, set up by Incline Therapeutics using acquired equipment and methods.

 


GRAPHIC

V DE-RISKED STRUCTURES

 


GRAPHIC

De-risked structures Low development risk and structured financial arrangements reduce early exposure Transaction structures suit our cash management and cash flow plans. Sufficient cash, attractive net income growth over time and adequate future cash flows from operations to take on these deals and subsequent operational commitments and milestones. Low development risk | reasonable regulatory risk | risk sharing structure From our anticipated cash position at the end of the year of $560-565M we will pay out $300M in up-front payments upon closing these deals. $115M to BMS – including a $10M option fee | $185M to Incline Therapeutics shareholders The BMS Recothrom® deal expected to be accretive from year 1. We believe there is further upside. The Incline Therapeutics deal is expected to be modestly dilutive in 2013 as we invest in manufacturing and technical development and regulatory work to support US and European filing in 2013 and 2014 Anticipate US submission in 2013 and approval in early 2014 and European approval in 2015 Ionsys is anticipated to reach peak sales of more than $800 million per year Subsequent payments may total $205M to Incline Therapeutics shareholders. These are contingent on milestones If we enter into an exclusive out-licensing arrangement with a Japanese firm which is expected to generate significant license fees and revenues; If Ionsys® is granted marketing authorization in the United States by the FDA and in the European Union by the EMA; and If Ionsys® achieves certain sales milestones. Further financial detail is provided on our website

 


GRAPHIC

De-risked structures Both assets have favorable risk profiles Risk factors Recothrom® - BMS Ionsys® - Incline Therapeutics Development Marketed product Line extension research in process Phase III trials completed 15 years of prior development leverage No safety/efficacy trials required PK/PD profile unchanged from original device Regulatory EU approval risk Line extension risk Clear FDA sNDA submission pathway Clear EU approval pathway Anticipate near term approval Q1 2014 Market place 35% market capture in 3 years Pricing pressure Safety based value proposition Large growing global market Encouraging EU launch in 2008 Clinical value proposition Pharmacoeconomic data Manufacturing Established Complex - barrier to entry 3 manufacturing lines developed 1st line assembled and producing product Total capacity for $2B (15M units) Financial Structured transaction - reduced up-front Exclusive back-end option to acquire Total consideration 3-3.2x revenue No increase in SG&A – adds firepower to Cleviprex® Less than 50% upfront Multiple approval and sales based milestones Attractive valuation relative to peak potential Leverage of SG&A requirements Human Highly motivated former Zymogenetics team Proven perioperative sales team in place Executive leadership Engineering/manufacturing from Alza Regulatory experience from Genentech

 


GRAPHIC

VI EFFECTIVELY TIMED REVENUE, CASH-FLOW AND EARNINGS DEVELOPMENT

 


GRAPHIC

Effectively timed revenue, cash flow and earnings development Sustainable growth anticipated Accretion | dilution Recothrom® deal is expected to be accretive to earnings in 2013 Incline Therapeutics deal is expected to be modestly dilutive for 2013-15 Combined the deals are neutral to slightly negative on a 2013 cash-flow basis Sustainable, attractive, revenue and – because these new products fit an established commercial channel – earnings growth These new products have the potential to drive immediate and long-term growth Accelerate near-term revenue growth “Fill the gap” around 2019 when Angiomax® US exclusivity is anticipated to become shared Potential for long-term exclusivity and continued growth of Ionsys beyond 2024 based on recently granted IP New products are Recothrom® and Ionsys®

 


GRAPHIC

VII PRINCIPLES OF INTEGRATION - MOVING FORWARD

 


GRAPHIC

Principles of integration Moving forward We expect to create the new merged leadership arrangements before closing Alan Levy, CEO of Incline Therapeutics will lead the Ionsys® innovation team reporting to MDCO Chief Executive Officer -- Incline team left to innovate BMS team will be merged and integrated into MDCO front line as soon as practical The combination will be reported and communicated in the context of the MDCO purpose and story We are focusing internal attention on the performance culture needed for the combined business going forward – from all three sides We will focus on the combined entity as an active champion for external stakeholders, including customers and shareholders from the beginning – just as each of the entities has been up to now We will identify the need for and undertake integration-critical learning real-time (and linked to real projects) – we will integrate where essential first

 


GRAPHIC

VIII SUMMARY AND IMMEDIATE STEPS